Trevi Therapeutics Inc (TRVI) 2024 Q2 法說會逐字稿

Good afternoon. And welcome to the Trevi Therapeutics second-quarter 2024 earnings conference call. (Operator Instructions) Please note this event is being recorded.

午安.歡迎參加 Trevi Therapeutics 2024 年第二季財報電話會議。（操作員說明）請注意此事件正在被記錄。

Various remarks that management makes during this conference call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor act, Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factor section of the company's most recent quarterly report on Form 10-Q, which the company filed with the SEC this afternoon. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its views change.

管理階層在本次電話會議上就公司未來預期、計畫和前景發表的各種言論均構成《安全港法案》、《1995 年私人證券訴訟改革法案》中安全港條款的前瞻性陳述。由於各種重要因素的影響，實際結果可能與這些前瞻性陳述所示的結果存在重大差異，包括公司向 SEC 提交的最新 10-Q 季度報告的風險因素部分中討論的因素今天下午。此外，任何前瞻性陳述僅代表本公司截至今日的觀點，不應被視為代表本公司截至任何後續日期的觀點。儘管該公司可能選擇在未來某個時候更新這些前瞻性陳述，但該公司明確表示不承擔任何這樣做的義務，即使其觀點發生變化。

I would now like to turn the conference over to Jennifer Good, Trevi's President and CEO. Please go ahead.

現在我想將會議交給 Trevi 總裁兼執行長 Jennifer Good。請繼續。

Good afternoon. And thank you for joining us for our second-quarter 2024 earnings call and business update. Joining me today on this call are my colleagues Lisa Delfini, Trevi's Chief Financial Officer; and Dr. David Clark, Trevi's Chief Medical Officer. I will give an update on the progress in our clinical trials and Lisa will give a brief financial update. Then the three of us are happy to answer any questions that you may have.

午安.感謝您參加我們的 2024 年第二季財報電話會議和業務更新。今天參加這次電話會議的是我的同事 Lisa Delfini，她是 Trevi 的財務長；以及 Trevi 首席醫療官 David Clark 博士。我將介紹我們臨床試驗的最新進展，麗莎將介紹簡短的財務最新情況。那麼我們三人很樂意回答您的任何問題。

This has been a fun but busy quarter at Trevi as we continue to execute against our clinical development plans for both chronic coughs and idiopathic pulmonary fibrosis, or IPF, as well as refractory chronic cough or RCC. We have a number of data readouts expected by year-end and are hoping to build on the strong efficacy data we saw in our Phase 2a trial in IPF chronic cough.

這是 Trevi 有趣但忙碌的一個季度，我們繼續執行針對慢性咳嗽和特發性肺纖維化 (IPF) 以及難治性慢性咳嗽 (RCC) 的臨床開發計劃。預計到年底我們將獲得大量數據，並希望以我們在 IPF 慢性咳嗽 2a 期試驗中看到的強大療效數據為基礎。

To support this fast pace and focus on execution, we continue to bolster our team, and we're happy to announce in April the hire of Dr. Meg Garin, who is key in progressing the clinical development of camlipixant while at Bellus Health. Meg is overseeing our RIVER trial day to day and has already started looking ahead to planning for our next trial. She has been a great addition to the team.

為了支持這種快節奏並專注於執行，我們繼續增強我們的團隊，我們很高興在 4 月宣布聘請 Meg Garin 博士，她在 Bellus Health 期間在推進 camlipixant 臨床開發方面發揮了關鍵作用。Meg 每天都在監督我們的 RIVER 試驗，並且已經開始為我們的下一次試驗進行規劃。她是團隊的重要補充。

Let me provide a brief update on our clinical trials, beginning with our Phase 2a RIVER trial in RCC, which is expected to read out in the fourth quarter of this year. RCC is a debilitating disease that affects approximately 2 million to 3 million US adults and is defined as a persistent cough lasting greater than eight weeks, despite treatment for an underlying condition or where no underlying condition exists.

讓我簡單介紹一下我們的臨床試驗的最新情況，首先是 RCC 的 2a 期 RIVER 試驗，預計將於今年第四季公佈。RCC 是一種使人衰弱的疾病，影響約 200 萬至 300 萬美國成年人，被定義為儘管治療了潛在疾病或不存在潛在疾病，但仍持續超過八週的持續咳嗽。

With a lack of any approved therapies for RCC in the US and several drug candidate failures, there continues to be a significant unmet need and an urgency from patients and providers for new therapies. We believe our key point of differentiation for Haduvio is the mechanism of action, which works synergistically both centrally in the brain and peripherally in the lungs. We believe this mechanism has the potential to work more broadly in RCC patients and potentially have a stronger effect across the broader range of baseline cough counts than peripheral-only mechanisms.

由於美國缺乏任何經批准的腎細胞癌治療方法，並且幾種候選藥物失敗，患者和提供者對新療法的需求仍然存在巨大的未滿足和緊迫性。我們相信 Haduvio 的差異化關鍵點在於其作用機制，它在大腦中央和肺部外周協同作用。我們相信，這種機制有可能在 RCC 患者中更廣泛地發揮作用，並且可能比僅外周機制在更廣泛的基線咳嗽計數範圍內產生更強的影響。

Our RCC trial is the standard Phase 2a crossover design that has been conducted across several cough trials run to-date and is planned to enroll approximately 60 patients. These patients will be randomized with a 1 to 1 stratification or approximately 30 in each arm between those with 10 to 19 coughs per hour, moderate cough, and those with greater than or equal to 20 coughs per hour, high cough.

我們的 RCC 試驗是標準 2a 期交叉設計，已在迄今為止運行的多項咳嗽試驗中進行，計劃招募約 60 名患者。這些患者將隨機分為 1 到 1 層，即每組約 30 名患者，分為每小時咳嗽 10 至 19 次的中度咳嗽患者和每小時咳嗽超過或等於 20 次的重度咳嗽患者。

This trial has been progressing nicely, and we now have approximately 80% of the subjects enrolled. Based on the current run rate, we expect to report data from this study in the fourth quarter of this year. However, I want to note that we currently have an imbalance in the enrolled subjects between the two stratification arms, i.e., the 10 to 19 and greater than 20 cough counts. The enrollment between the two arms has fluctuated throughout the study.

這項試驗進展順利，目前約有 80% 的受試者入組。根據目前的運行速度，我們預計將在今年第四季報告這項研究的數據。然而，我想指出的是，我們目前兩個分層組之間的入組受試者不平衡，即咳嗽次數為 10 至 19 次和大於 20 次。在整個研究過程中，兩組之間的入學人數有所波動。

This is important data to inform future development, and there may be a scenario where we get to our overall planned N of 60 but keep the study open a little longer to balance the arms. We are excited to complete the enrollment of this study and report the data in this important chronic cough condition.

這是為未來發展提供資訊的重要數據，並且可能存在這樣一種情況：我們達到了總體計劃的 60 個 N，但將研究開放的時間更長一些，以平衡各個方面。我們很高興完成這項研究的招募並報告這種重要的慢性咳嗽病症的數據。

Next, an update on our lead program in IPF chronic cough. IPF is a serious end-of-life disease. Chronic cough is reported by approximately 85% of patients suffering from IPF and has significant physical, psychological, and social impacts.

接下來，我們介紹了 IPF 慢性咳嗽主導計畫的最新情況。IPF 是一種嚴重的臨終疾病。據報導，大約 85% 的 IPF 患者患有慢性咳嗽，並具有顯著的身體、心理和社會影響。

Cough may also be a risk factor that plays a role in the progression of the underlying disease. The constant lung injury, micro tears, and inflammation caused by persistent coughing may lead to worstehealth outcomes for patients. With no currently approved treatment options for chronic cough in IPF, patients and providers have an urgent need for new therapies.

咳嗽也可能是在基礎疾病進展中發揮作用的危險因子。持續咳嗽引起的持續性肺損傷、微撕裂和發炎可能會給患者帶來最糟糕的健康結果。由於目前還沒有批准治療 IPF 慢性咳嗽的治療方案，患者和醫療服務提供者迫切需要新的療法。

Our IPF chronic cough trial, CORAL is a Phase 2b parallel arm dose ranging study that will investigate three active doses of Haduvio and placebo. The study is a six-week trial in approximately 160 patients. We are conducting this study in multiple countries and sites to be able to complete enrollment in a timely manner. We now have the majority of our sites activated, and enrollment is progressing nicely. We have great relationships with the investigators in the trial and are communicating with them frequently to ensure our study is top of mind.

我們的 IPF 慢性咳嗽試驗 CORAL 是一項 2b 期平行臂劑量範圍研究，將研究 Haduvio 和安慰劑的三種活性劑量。該研究對大約 160 名患者進行了為期六週的試驗。我們正在多個國家和地點進行這項研究，以便能夠及時完成招募。現在，我們的大部分網站已激活，註冊進展順利。我們與試驗中的研究人員有著良好的關係，並經常與他們溝通，以確保我們的研究是首要考慮的。

The next milestone in this study is to conduct a sample size re-estimation, SSRE analysis, when 50% of the patients complete. This analysis will be done by an unblinded statistician external to the company who will rerun the power calculations using actual data.

本研究的下一個里程碑是在 50% 的患者完成時進行樣本量重新估計（SSRE 分析）。該分析將由公司外部的非盲統計學家完成，他將使用實際數據重新運行功率計算。

We will get very limited information back, but we will be informed of one of the following three outcomes. One, continue on as planned with the current planned number of patients, reconfirming the original powering assumptions. Two, the drug is working within the pre-specified promising zone but will require an upsize in the number of patients to maintain the power. Or three, the drug is not working in the pre-specified range and the company should consider stopping.

我們將得到非常有限的信息，但我們將被告知以下三種結果之一。第一，繼續按計劃處理目前計劃的患者數量，再次確認最初的供電假設。第二，該藥物正在預先指定的有希望的區域內發揮作用，但需要增加患者數量才能維持功效。或者第三，藥物沒有在預先指定的範圍內起作用，公司應該考慮停止。

We will announce the results of this analysis, and we'll have the information, which we expect in the fourth quarter of this year. We continue to expect topline data for the full study in the first half of 2025, subject to the result of the SSRE.

我們將公佈這項分析的結果，我們預計將在今年第四季獲得資訊。我們繼續預期 2025 年上半年完整研究的主要數據，具體取決於 SSRE 的結果。

We also are conducting two important supportive studies this year, the human abuse potential or HAP study, as well as the respiratory physiology study. I will give you a quick update on both. The HAP study is currently 95% enrolled and will require one more cohort of dosing to complete. We expect a complete enrollment and dosing in the third quarter, with data from this study reported in the fourth quarter.

今年我們也進行了兩項重要的支持性研究，人類濫用潛力或 HAP 研究，以及呼吸生理學研究。我將為您提供有關兩者的快速更新。目前 HAP 研究的入組率為 95%，需要再進行一組給藥才能完成。我們預計第三季將完成入組和給藥，該研究的數據將在第四季度報告。

Finally, we have initiated a Phase 1 respiratory physiology study, which is being conducted to systematically measure respiratory function in varying levels of disease severity and IPF to help determine our Phase 3 patient population. To-date, we have excluded sleep-disordered breathing patients in our clinical studies and we want to better characterize the safety overall in the patient population.

最後，我們啟動了一項第一階段呼吸生理學研究，該研究旨在系統地測量不同疾病嚴重程度和 IPF 水平的呼吸功能，以幫助確定我們的第三階段患者群體。迄今為止，我們已在臨床研究中排除了睡眠呼吸障礙患者，我們希望更好地描述患者群體的整體安全性。

The protocol has been approved in both the US and the UK, and the study has initiated patient screening. We expect to enroll approximately 25 patients that will be inpatient for 10 days. The primary endpoint of the trial is the effect of escalating doses of Haduvio on respiratory function as measured by minute ventilation. Secondary endpoint measures of additional respiratory functions are also included.

該方案已在美國和英國獲得批准，研究已啟動患者篩檢。我們預計將招募約 25 名住院 10 天的患者。該試驗的主要終點是增加劑量的 Haduvio 對每分鐘通氣量測量的呼吸功能的影響。也包括其他呼吸功能的次要終點測量。

As you can see, these studies have progressed nicely and data from these trials will be important to inform the development path forward for Haduvio in chronic cough conditions. I want to thank our team who have worked hard to keep the enrollment on plan. We look forward to completing these clinical trials and reporting out the data beginning in the fourth quarter of this year.

正如您所看到的，這些研究進展順利，這些試驗的數據對於指導 Haduvio 在慢性咳嗽疾病中的發展道路非常重要。我要感謝我們的團隊，他們為確保招生按計劃進行而付出了巨大的努力。我們期待在今年第四季開始完成這些臨床試驗並報告數據。

I will now turn it over to Lisa to review our financial results, and we will open it up for any questions you may have.

我現在將把它交給麗莎來審查我們的財務業績，我們將開放它來回答您可能有的任何問題。

Thank you, Jennifer, and good afternoon, everyone. The full financial results for the three months ended June 30, 2024, can be found in our press release issued ahead of this call and our 10-Q which was filed with the SEC today after the market closed.

謝謝你，詹妮弗，大家下午好。截至 2024 年 6 月 30 日的三個月的完整財務業績可以在我們在本次電話會議之前發布的新聞稿以及今天收盤後向 SEC 提交的 10-Q 中找到。

For the second quarter of 2024, we reported a net loss of $12.4 million, compared to a net loss of $7.1 million for the same quarter in 2023. R&D expenses were $10 million during the second quarter of 2024, compared to $5.8 million in the same quarter in 2023, which reflects a strong clinical activity across all four of our trials.

2024 年第二季度，我們報告淨虧損 1,240 萬美元，而 2023 年同一季度的淨虧損為 710 萬美元。2024 年第二季的研發費用為 1,000 萬美元，而 2023 年同一季度的研發費用為 580 萬美元，這反映了我們所有四項試驗的強勁臨床活動。

G&A expenses were $3.3 million during the second quarter of 2024 compared to $2.5 million in the same period of 2023, primarily due to increases in personnel and related expenses, market research costs, and information technology services.

2024 年第二季的一般管理費用為 330 萬美元，而 2023 年同期為 250 萬美元，主要是由於人員和相關費用、市場研究成本和資訊科技服務的增加。

As of June 30, 2024, our cash, cash equivalents, and marketable securities totaled $69.5 million, compared to $83 million as of December 31, 2023.

截至 2024 年 6 月 30 日，我們的現金、現金等價物及有價證券總額為 6,950 萬美元，截至 2023 年 12 月 31 日為 8,300 萬美元。

During the quarter, we issued approximately 1.5 million shares from our ATM, which was purchased by a single buyer. This cash inflow strengthens our runway post data readouts on our current clinical trials. We continue to expect that our cash burn, excluding the proceeds from the share issuance, will average $9 million to $12 million per quarter in 2024, and we will have cash runway into 2026.

本季度，我們透過 ATM 發行了約 150 萬股股票，由一位買家購買。這筆現金流入增強了我們目前臨床試驗的跑道後數據讀數。我們仍然預計，到 2024 年，我們的現金消耗（不包括股票發行收益）將平均每季 900 萬至 1,200 萬美元，我們將有現金跑道持續到 2026 年。

This concludes our prepared remarks. I will now turn the call back over to the Operator for Q&A.

我們準備好的演講到此結束。我現在將把電話轉回接線生進行問答。

(Operator Instructions) Annabel Samimy, Stifel.

（操作員說明）Annabel Samimy，Stifel。

Hi. This is [Adam] calling in for Annabel. Congrats on the progress this quarter. I had two questions. The first is related to RIVER chronic costs. When you guys were designing the trial, did you use different powering assumptions for the different severity groups being studied or are they powers of the same treatment effect?

你好。我是[亞當]打電話給安娜貝爾。恭喜本季取得的進展。我有兩個問題。第一個與 RIVER 長期成本有關。當你們設計試驗時，你們是否對所研究的不同嚴重程度組別使用了不同的功效假設，或者它們是否具有相同治療效果的功效？

And then the second question is related to the human abuse potential study. Can you confirm that nalbuphine is not a scheduled drug while butorphanol is Schedule IV? If that's the case, is there any reason that you would expect any -- would there be any reason to expect that there would be a dose response to likability for the ER formulation? Has there been any indication from the FDA that there was a plan to potentially reschedule nalbuphine ER?

第二個問題與人類虐待潛能研究有關。您能否確認納布啡不是附表藥物，而布托啡諾則是附表 IV 藥物？如果是這樣的話，您是否有任何理由期望 ER 製劑的好感度會出現劑量反應？FDA 是否有任何跡象表明有可能重新安排納布啡 ER 的計劃？

I'm going to let David answer the powering assumptions for each arm, and then I'll take on the half question.

我將讓 David 回答每隻手臂的動力假設，然後我將回答一半的問題。

Yeah, no. So as you know, the primary endpoint in RIVER is the total population N of 60. So that's the primary analysis. But you're really requesting -- what you're asking about is the subgroup analyses. We made the same assumptions for the effect size in those subgroup analysis.

是的，不。如您所知，RIVER 的主要終點是總人口 N 為 60。這就是初步分析。但你真正要求的是──你所要求的是亞組分析。我們對這些亞組分析中的效應大小做出了相同的假設。

And then for the human abuse potential analysis, Adam, I mean, nalbuphine is been around for decades. It's been unscheduled by the DEA, and it gets looked at regularly, and they continue to unschedule the drug. We also have a lot of information on it. All the preclinical work was done. We have our whole clinical database, et cetera.

然後，對於人類濫用潛力分析，亞當，我的意思是，納布啡已經存在了幾十年。美國緝毒局沒有對此進行安排，但會定期進行檢查，並且他們會繼續對藥物進行安排。我們也有很多這方面的資訊。所有臨床前工作均已完成。我們擁有整個臨床資料庫等等。

So we feel, based on what we know, the drug should remain unscheduled. There is sort of this last piece to bring it up to current standards, the human abuse potential study. I guess we'll run the study. We'll see the data. It'll be part of the analysis. They look at sort of eight different factors, of which that's one.

因此，我們認為，根據我們所知，該藥物應該保持未安排的狀態。最後一項工作可以使其達到當前標準，即人類虐待潛力研究。我想我們會進行這項研究。我們會看到數據。這將是分析的一部分。他們考察了八種不同的因素，這只是其中之一。

But I would just sort of bring everyone back to, there's two pieces of the mechanism in our drug, mu antagonists, none of which are scheduled, and kappa agonists, none of which are scheduled. So it seems a little bit unusual.

但我想讓大家回想一下，我們的藥物中有兩種機制，mu 拮抗劑，其中沒有一個是預定的，以及 kappa 激動劑，其中沒有一個是預定的。所以這看起來有點不尋常。

Butorphanol, just to draw that comparison, is a weak mu-agonist kappa agonist. We're a mu-antagonist kappa agonist. So I don't want to say there's no scenario where that happens, but we're feeling pretty good about our drug and have not sort of seen issues with that. But clearly, you have to run the study and see the data, and then we'll submit everything when we get it.

為了進行比較，布托啡諾是一種弱的 mu 激動劑 kappa 激動劑。我們是 mu 拮抗劑 kappa 激動劑。所以我不想說這種情況不會發生，但我們對我們的藥物感覺很好，並且沒有發現任何問題。但顯然，您必須進行研究並查看數據，然後我們將在獲得數據後提交所有內容。

Thomas Smith, Leerink Partners.

托馬斯史密斯，Leerink 合夥人。

Congrats on the progress. Just on the respiratory physiology study, I was wondering if you could comment on your expectations on enrollment in terms of patient disease severity that you're enrolling into the study. And then also just comment on the doses that you'll be evaluating in that study and how that compares to what you're looking at in the IPF and RCC studies?

祝賀取得的進展。就呼吸生理學研究而言，我想知道您是否可以評論一下您對參與研究的患者疾病嚴重程度的期望。然後評論一下您將在該研究中評估的劑量，以及與您在 IPF 和 RCC 研究中觀察到的劑量相比如何？

Sure. I'm going to let David take that.

當然。我會讓大衛接受這個。

So the doses we're studying are the same that we have in both RIVER and CORAL. We're studying up to 108 milligrams BID in that inpatient study. And sorry, the first part of your question was?

因此，我們正在研究的劑量與河流和珊瑚中的劑量相同。我們在那項住院病患研究中研究了高達 108 毫克 BID 的劑量。抱歉，您問題的第一部分是？

Disease severity, healthcare.

疾病嚴重程度，醫療保健。

So we start the study, in essence, in the same population which we're studying in CORAL. So the IPF diagnosis and, in essence, the same population. And then once we have data from that initial group, we would expand the population, as we've disclosed previously, to include sleep-disordered breathing subtypes. So that would be added onto the study and including all varieties of sleep-disordered breathing in that study so that we can address the primary question, which is for Phase 3, we would like to include a broad range of IPF patients in Phase 3, so we can address that question.

因此，我們本質上是在與 CORAL 研究相同的人群中開始研究。所以IPF的診斷本質上和人群是一樣的。然後，一旦我們獲得了初始群體的數據，我們就會擴大人群，正如我們之前所揭露的那樣，將睡眠呼吸障礙亞型納入其中。因此，這將被添加到研究中，並在該研究中包括所有類型的睡眠呼吸障礙，以便我們可以解決第 3 階段的主要問題，我們希望在第 3 階段包括廣泛的 IPF 患者，所以我們可以解決這個問題。

Got it. That's helpful. And then just, if I could ask a follow-up on RIVER, I was wondering if you could just elaborate on the enrollment balance between the moderate and severe patients that you're seeing. Are we seeing more moderate or severe? And are there any other baseline characteristics that you have visibility into that maybe differ from your initial expectations or some of the other contemporary Phase 2 RCC studies?

知道了。這很有幫助。然後，如果我可以詢問 RIVER 的後續情況，我想知道您是否可以詳細說明您所看到的中度和重度患者之間的入組平衡。我們看到的是更溫和還是更嚴重？您所了解的其他基線特徵是否可能與您最初的預期或其他一些當代 2 期 RCC 研究不同？

Yeah. So we don't comment, Tom, on all the sort of specifics within the trial midstream because things go back and forth. I would say, there's sort of a bit of an imbalance, but that's gone both ways. At one point, one arm's a little further ahead than the other. So we'll sort of lay all that out by subgroup when we get to the end.

是的。因此，湯姆，我們不會對試驗中途的所有具體細節發表評論，因為事情會反覆發生。我想說，確實有點不平衡，但這是雙向的。在某一時刻，一隻手臂比另一隻手臂稍微領先一點。因此，當我們到達最後時，我們將按小組排列所有內容。

I would say, as far as baseline characteristics, I can tell you when Meg came in, she went through sort of all the subjects enrolled and sort of all their medical information. And David, you can comment as well, and felt it looked good, good diagnoses, nothing unusual based on what she saw.

我想說，就基線特徵而言，我可以告訴你，當梅格進來時，她檢查了所有登記的受試者及其所有醫療資訊。大衛，你也可以發表評論，根據她所看到的情況，感覺看起來不錯，診斷良好，沒有什麼異常。

Absolutely right. I mean, and which is what we expected. We've -- it's one of the advantages of these smaller Phase 2a studies. You can go to really very super expert centers for your trial and so that's what we expected and that's what we've seen.

完全正確。我的意思是，這正是我們所期望的。我們已經——這是這些較小的 2a 期研究的優點之一。你可以去非常非常超級的專家中心進行試驗，這就是我們所期望的，這就是我們所看到的。

Leland Gershell, Oppenheimer.

利蘭·格謝爾，奧本海默。

I just want to ask, as you think about the evolution of the development programs and we're coming up on the RCC topline data, and as you continue developing Haduvio in IPF chronic cough, would the outcome of the RCC trial impact upon your plans in IPF? In other words, would you look to prioritize Haduvio in RCC? Would that alter kind of the weight you put on the IPF opportunity? Just wondering how you think about those two side-by-side should RCC print out a strong data set?

我只是想問，當您考慮開發計劃的演變時，我們正在研究 RCC 的頂線數據，當您繼續開發用於 IPF 慢性咳嗽的 Haduvio 時，RCC 試驗的結果是否會對您的計劃產生影響在IPF ？換句話說，您會考慮在 RCC 中優先考慮 Haduvio 嗎？這會改變您對 IPF 機會的重視嗎？只是想知道您如何看待這兩個並列的 RCC 是否應該列印出強大的資料集？

Yeah. It's a good question, Leland. We talk about it a lot as a team and a board. There's a big commitment inside Trevi to that IPF is our lead indication. Severe unmet need, not a lot of options for those patients, cough is a big problem. We also, as I laid out in my comments, we believe that cough is potentially contributing to the underlying disease and so how we might sort of look at some of those endpoints in an exploratory way.

是的。這是個好問題，利蘭。我們作為團隊和董事會經常談論這個問題。Trevi 內部有一個重大承諾，即 IPF 是我們的主要適應症。嚴重未滿足的需求，對於那些患者來說沒有很多選擇，咳嗽是一個大問題。正如我在評論中所述，我們也認為咳嗽可能導致潛在的疾病，因此我們如何以探索性的方式看待其中一些終點。

RCC is interesting because there is unmet need there and how that eventually merges with IPF is sort of a question we'll have to wrestle with. I think as Trevi, we would look to probably pick up sort of the most, assuming the P2X3 camlipixant gets approved, we would probably look to be third-line therapy behind that for the failures, because we'd want to maintain the pricing we have in IPF. We think today that's probably the optimal way to maximize the value of the drug. Now, in somebody else's hands that's got a bigger sales force, that may not be the case.

RCC 很有趣，因為那裡有未滿足的需求，而它最終如何與 IPF 合併是我們必須努力解決的問題。我認為，作為 Trevi，我們可能會尋求最多的機會，假設 P2X3 camlipixant 獲得批准，我們可能會尋求成為失敗的三線療法，因為我們希望維持我們的定價有IPF。我們認為今天這可能是最大化藥物價值的最佳方式。現在，在擁有更大銷售團隊的其他人手中，情況可能並非如此。

So I would think about this, assuming the data supports it, that Trevi is going to be leading with its IPF program and studying RCC with an eye towards picking up the most severe coughers that aren't getting relief anywhere else. And that could be, by the way, in this moderate cough count, if they're not able to be treated. But that's, we've done some modeling this summer, and I think that's how we believe we could best optimize it.

因此，我會考慮這一點，假設數據支持這一點，Trevi 將領導其 IPF 計劃並研究 RCC，著眼於找出在其他地方無法緩解的最嚴重的咳嗽者。順便說一句，如果他們無法得到治療，這可能是在中度咳嗽計數。但那就是，我們今年夏天做了一些建模，我認為這就是我們相信我們可以最好地優化它的方式。

Mayank Mamtani, B. Riley Securities.

Mayank Mamtani，B. Riley 證券。

Congrats on the progress. On the Phase 2a RIVER protocol, could you just remind us how that differs from the Phase 2a CANAL that you previously executed on very successfully? And then I'll have a quick follow-up.

祝賀取得的進展。關於 2a 階段 RIVER 協議，您能否提醒我們這與您之前非常成功執行的 2a 階段 CANAL 有何不同？然後我會進行快速跟進。

Thank you so much for the question. So the design, as you know, is in essence the same. The only difference we made is based on the early efficacy signal that we saw in the CANAL design, where we went up to 162 milligrams BID. We capped the dose at 108 BID. So the dose, we reduced compared to CANAL, and we increased the washout period up to three weeks.

非常感謝你的提問。因此，正如您所知，設計本質上是相同的。我們所做的唯一區別是基於我們在 CANAL 設計中看到的早期功效訊號，我們將 BID 提高到了 162 毫克。我們將劑量限制為 108 BID。因此，與 CANAL 相比，我們減少了劑量，並將沖洗期延長至三週。

There's another minor difference as well. CANAL was run when COVID was very active, and we could only get the objective cough endpoint at baseline in week three. Here, we've gone back to the more we were able to get weekly objective cough data, which was always the aim in CANAL, but COVID got in the way.

還有另一個細微差別。CANAL 是在新冠病毒非常活躍的時候運行的，我們只能在第三週獲得基線的客觀咳嗽終點。在這裡，我們回到了我們能夠獲得每週客觀咳嗽數據的情況，這一直是 CANAL 的目標，但新冠疫情阻礙了這一點。

Very helpful. Thank you. And then on the PROs, which we all know is an important regulatory topic also, could you just remind us what you're looking for in CORAL, obviously? And then is RIVER also going to give us some more information on some of these PROs? And then I have one more question after that.

非常有幫助。謝謝。然後，關於 PRO，我們都知道這也是一個重要的監管主題，您能否提醒我們您在 CORAL 中尋找什麼？那麼 RIVER 是否也會向我們提供一些有關其中一些 PRO 的更多資訊？之後我還有一個問題。

Yeah. David?

是的。大衛？

Yeah. So we increased the range of PROs, and I'll start with the CORAL study first, compared to the CANAL study. So in CORAL, we basically have the opportunity to profile both with cough frequency score, that's we're using the exact, which was the same endpoint we used in Phase 2a in CANAL.

是的。因此我們增加了 PRO 的範圍，我將首先從 CORAL 研究開始，與 CANAL 研究進行比較。因此，在 CORAL 中，我們基本上有機會透過咳嗽頻率評分來分析兩者，也就是說，我們使用的是精確的端點，這與我們在 CANAL 階段 2a 中使用的端點相同。

But we've also expanded quite broadly, living with IPF. A lot of PROs, which allow you to get a good feel for the overall clinical characteristics and the improvements, including functional improvements that you get. So we've got a broad range of PROs. So less the cough questionnaire you would expect. Living with IPF is a very good instrument.

但我們也進行了相當廣泛的擴展，與 IPF 一起生活。很多 PRO，可以讓您很好地感受到整體臨床特徵和改進，包括您獲得的功能改進。所以我們有廣泛的專業人士。因此，您所期望的咳嗽問卷就更少了。與 IPF 一起生活是一個非常好的工具。

And then standard anchor measurements, patient's global impression of severity and change in cough and IPF. Those are the sorts of measures. Those are some of the most important PROs we added there.

然後是標準錨測量、患者對咳嗽和 IPF 嚴重程度和變化的總體印象。這些都是措施。這些是我們在那裡添加的一些最重要的 PRO。

And we took a similar approach, frankly, even in the small RIVER study. So there, the important secondary endpoints of PROs would be cough frequency again, living the less the cough questionnaire, and cough severity.

坦白說，即使在小型河流研究中，我們也採取了類似的方法。因此，PRO 的重要次要終點將再次是咳嗽頻率、咳嗽問卷調查以及咳嗽嚴重程度。

We're using the VAS measurement, because that's used in the majority of RCC programs, so it's a good comp compared to other programs. We may at some stage switch to the cough severity NRS measurement, because regulatory wise, that'll probably be a better endpoint for approvals, but that's a relatively small detail. So, and then again, good anchor with patient global impression of severity and change in cough in the RIVER study as well.

我們使用 VAS 測量，因為大多數 RCC 專案都使用它，所以與其他專案相比，它是一個很好的比較。我們可能會在某個階段轉向咳嗽嚴重程度 NRS 測量，因為從監管角度來看，這可能是一個更好的批准終點，但這是一個相對較小的細節。因此，話又說回來，在 RIVER 研究中，患者對咳嗽嚴重程度和變化的整體印像也很好。

And then lastly, on your earlier comment, Jennifer, on the focus on severe cough cohort or maybe refractory to P2X3. Is that a more recent development or is that something that you're just going to be data dependent on what you learn from RCC? And I just ask that because your final dose ranging work could give you a different dose in those two different indications. So…

最後，珍妮佛，關於您先前的評論，關於對嚴重咳嗽人群或可能對 P2X3 抗藥性的人群的關注。這是最近的發展，還是您將依賴您從 RCC 中學到的數據？我只是問這個，因為您的最終劑量範圍工作可能會在這兩種不同的適應症中為您提供不同的劑量。所以…

Yeah.

是的。

I was just curious how tied you are to the idea of pegging yourself to the idea of chronic cough indications.

我只是很好奇你對將自己與慢性咳嗽症狀掛鉤的想法有多麼緊密的聯繫。

It's a good question, Mayank. Like I said, it's something we debate a lot. I would say it's been -- it's come out of a bit of work this summer and you are right. This is all going to be data driven. So obviously, these are two big indications, a lot of unmet need in both. So lots of opportunity here.

這是一個很好的問題，梅揚克。就像我說的，這是我們經常爭論的問題。我想說的是，這是今年夏天的一些工作的結果，你是對的。這一切都將由數據驅動。顯然，這是兩個重要的跡象，兩者都有許多未滿足的需求。這裡有很多機會。

I think what we've been wrestling with a bit as a small company. IPF is very – we can take that all the way through approval and if we had to commercialize it, it's a very specialty sales force. So we feel really comfortable with that model.

我想我們作為一家小公司一直在努力解決這個問題。IPF 非常 - 我們可以一直通過批准，如果我們必須將其商業化，它是一支非常專業的銷售團隊。所以我們對這個模型感到非常滿意。

RCC starts to open sort of that can of worms a lot broader. So the work that our colleague has done a lot this summer is trying to figure out how you could maintain the premium pricing that we think we can get in IPF into an RCC population.

RCC 開始將蠕蟲的範圍擴大到更廣泛的範圍。因此，我們的同事今年夏天做了大量的工作，試圖找出如何維持我們認為可以在 IPF 中為 RCC 人群提供的溢價。

But those decisions are by no means final. I would just say that's probably out of some research this summer and thinking about how to optimize it without cannibalizing IPF. That's our current thinking.

但這些決定絕不是最終決定。我只想說，這可能是今年夏天的一些研究以及思考如何在不蠶食 IPF 的情況下對其進行最佳化的結果。這就是我們目前的想法。

But on the other hand, the RCC market's big enough and that's what I say. In somebody else's hands, it's already got an existing sales force. You could see them launch much more broadly because they don't have the cost sort of associated with building that.

但另一方面，RCC 市場足夠大，這就是我所說的。在別人的手中，它已經擁有了一支現有的銷售團隊。你可以看到它們的推出範圍更廣，因為它們沒有與建造相關的成本。

So you're right. It'll be data dependent. Really not something we have to decide for a while. I mean, we'll continue on. We'll run the next study. But at some point, somebody's got to wrestle with that question.

所以你是對的。這將取決於數據。確實不是我們必須暫時決定的事情。我的意思是，我們會繼續。我們將進行下一項研究。但在某些時候，有人必須努力解決這個問題。

Yeah. Makes a lot of sense and good to be ahead of that. Thanks again for taking our questions and look forward to your future updates.

是的。領先這一點很有意義，也很好。再次感謝您提出我們的問題，並期待您未來的更新。

Yeah. Thank you, Mayank.

是的。謝謝你，瑪雅克。

Brandon Folkes, Rodman & Renshaw.

布蘭登福克斯、羅德曼和倫肖。

Maybe just firstly on the HAP data readout, in terms of a positive outcome, is it really as long as we don't see a dose-dependent likability, that that's a positive outcome for you and strengthens your discussions with the agency, so that even if we see high likability in one of the groups, I'm sure we'll see some likability. But as long as it's not dose-dependent, should we interpret that as a positive and strengthening your discussion with the agency?

也許首先就 HAP 數據讀數而言，就積極結果而言，只要我們沒有看到劑量依賴性的好感度，這對您來說就是一個積極的結果，並加強了您與該機構的討論，以便即使我們在其中一個群體中看到很高的可愛度，我相信我們也會看到一些可愛度。但只要它不是劑量依賴性的，我們是否應該將其解釋為積極的並加強您與該機構的討論？

So, Brandon, that's a good question. Like all data, it's sort of the gestalt of what you see. I would say, there's a published paper Cara did with their kappa agonist, where they showed separation from placebo, but they were less likable than their comparator pentazocine. They only had one dose, so the dose-response question wasn't there. That drug was left unscheduled. So I think at a baseline on data, we will likely separate from placebo, but hopefully be less likable or similar to our comparator. I think that puts us in a strong situation.

所以，布蘭登，這是一個很好的問題。與所有資料一樣，它是您所看到的資料的完形。我想說的是，卡拉用他們的 kappa 激動劑發表了一篇論文，其中顯示它們與安慰劑不同，但它們不如比較藥物噴他佐辛討人喜歡。他們只注射了一劑，因此不存在劑量反應問題。該藥物未按計劃使用。因此，我認為在數據基線上，我們可能會與安慰劑分開，但希望與我們的比較劑不太討人喜歡或相似。我認為這使我們處於有利的境地。

Now, having said that, you are right that what the FDA really has concerns, if there's a little bit of signals and likability, that you don't see the dose dependence, because you don't want to see somebody like it a bit, and then you take sort of 3x the dose, and they like it 3 times more. So it's a bit of all of that combined. So it's certainly something we'll look at.

現在，話雖如此，你是對的，FDA 真正擔心的是，如果有一點信號和好感，你就看不到劑量依賴性，因為你不想看到有人有點喜歡它，然後你服用3 倍的劑量，他們就會喜歡3 倍的劑量。所以這是所有這些的結合。所以這肯定是我們會關注的事情。

But our expectation is this drug should not be all that likable. I mean, you've looked at our adverse events profile and we just don't see that. So when we get all the data, we'll lay it out for the street and also have an expert to help sort of interpret what we've seen and our own conclusions around it.

但我們的期望是這種藥物不該那麼受歡迎。我的意思是，您已經查看了我們的不良事件概況，但我們只是沒有看到這一點。因此，當我們獲得所有數據後，我們會將其展示給街道，並請專家幫助解釋我們所看到的內容以及我們自己的結論。

Great. Very helpful. And then maybe just shifting gears into the respiratory study, in a way to characterize what you think the hurdle right here is to include sleep disorder patients going forward, or is it also a case of generate the data and then have the conversation with the agency in terms of whether it's enough to get these sleep disorder patients or do you think there's a finite hurdle here that the agency wants to see?

偉大的。非常有幫助。然後也許只是轉向呼吸研究，以某種方式來描述你認為這裡的障礙是包括睡眠障礙患者，或者這也是生成數據然後與該機構進行對話的情況就是否足以接收這些睡眠障礙患者而言，還是您認為該機構希望看到的障礙有限？

Regards to the respiratory physiology study, I think there are well-established endpoints and markers of what is a clinically relevant change in minute ventilation, which, for example, which is the primary endpoint which we can utilize. So actually, we think the signal of the study will be relatively interpretable ourselves when we get this, because in clinical practice, there are fairly clear guidance as to what is a clinically relevant change in all the endpoints we're looking at.

關於呼吸生理學研究，我認為每分鐘通氣量的臨床相關變化有明確的終點和標記，例如，這是我們可以利用的主要終點。因此，實際上，我們認為當我們得到這個結果時，我們自己可以相對解釋研究的信號，因為在臨床實踐中，對於我們正在研究的所有終點的臨床相關變化是什麼，有相當明確的指導。

So we believe that the results of the study will be interpretable by ourselves. I don't -- it's definitely not our thinking that we have to -- it's mandatory that we have to go back to the FDA and have some discussion. As part of an end of Phase 2 meeting, we'll have this data set, but we think it'll be more straightforward than, no, here's a detailed discussion about the relevance of all these findings.

所以我們相信研究結果可以由我們自己解釋。我不——這絕對不是我們的想法——我們必須回到 FDA 並進行一些討論。作為第二階段會議結束的一部分，我們將擁有這個數據集，但我們認為它會比「不，這裡有關於所有這些發現的相關性的詳細討論」更簡單。

Thanks. That's very helpful. And then maybe lastly, just following up on a few of the earlier comments, just on the RIVER imbalance between the two arms. You talked about sort of how this has fluctuated throughout the study. Is this just a normal part of the fluctuation and of that cycle, or has one patient group become a little bit more competitive to enroll going forward? I know you're not giving color on which patient group, but is there sort of a fundamental competition for one of these patient groups, or is it just normal fluctuation? Thank you.

謝謝。這非常有幫助。也許最後，只是跟進一些先前的評論，只是關於兩隻手臂之間河牌不平衡的問題。您談到了在整個研究過程中這一點是如何波動的。這只是波動和週期的正常部分，還是某個患者群體在未來的註冊方面變得更具競爭力？我知道您沒有具體說明哪個患者群體，但是其中一個患者群體是否存在根本性競爭，或者這只是正常波動？謝謝。

We always expected -- you're always going to get one group's going to recruit a little bit faster than the others, but we expect -- we weren't predicting which one, frankly. The difference here that Jennifer was speaking to is the difference was a little bit larger than we expected, and that's why, as we've always explained, we think approximately 30 subjects per group in these two subgroups, the 10 to 19 and the greater than 20 patients, will allow us to detect a clinically meaningful effect size.

我們一直期望——你總是會讓一個團隊比其他團隊更快地招募人員，但我們期望——坦白說，我們並沒有預測是哪一個。Jennifer 所說的這裡的差異是差異比我們預期的要大一些，這就是為什麼，正如我們一直解釋的那樣，我們認為這兩個亞組（10 到19 以及更大的組）中每組大約有30 名受試者。

We've got more than 80% power in both of these subgroups with about approximately 30 subjects to detect a mid-30% effect size on top of placebo. And for that reason, we think it's important to stick with that stated aim, and that's what Jennifer was speaking to. So the difference was the imbalance was a little bit larger than we were expecting when we started the study, but we always knew there'd be one group that would recruit quicker.

我們在這兩個亞組中的大約 30 名受試者中獲得了超過 80% 的功效，在安慰劑的基礎上檢測到中等 30% 的效應大小。基於這個原因，我們認為堅持既定目標很重要，這就是珍妮佛所說的話。因此，不同之處在於，不平衡程度比我們開始研究時預期的要大一些，但我們一直知道會有一組能夠更快地招募人員。

And it's a difference of a month or two of recruiting. So, we'll just see how it comes together. This issue could go away. I'm just reminding people of the protocol and that that could come up at the end of the study.

而且招募時相差一兩個月。所以，我們將看看它是如何組合在一起的。這個問題可能會消失。我只是提醒人們注意協議以及研究結束時可能會出現的內容。

John Gionco, Needham & Company.

約翰‧吉昂科，李約瑟公司。

Hi. This is John on for Serge today. First, surrounding the IP for nalbuphine, can you provide an overview of the current patent coverage and if any additional applications are outstanding at this time and whether the existing method of use IP applies equally to both IPF and RCC?

你好。這是今天為 Serge 發言的約翰。首先，圍繞著納布啡的智慧財產權，您能否概述一下目前的專利覆蓋範圍，目前是否有其他申請尚未完成，以及現有的智慧財產權使用方法是否同樣適用於 IPF 和 RCC？

So we have issued method of treatment patents. We have a set of formulation patents that protect the product till roughly 2030, but we have issued method of treatment patents, which is really the core of the protection that are issued through 2039 for IPF costs. We do have worldwide rights and patents that we've prosecuted around that.

所以我們已經頒發了治療方法專利。我們擁有一套配方專利，可以將產品保護到大約 2030 年，但我們已經頒發了治療方法專利，這實際上是 2039 年頒發的 IPF 成本保護的核心。我們確實擁有全球權利和專利，並已為此提起訴訟。

There are some additional applications being prosecuted as well concerning other clinical work we've done around the label, things like dosing in the elderly or hepatically impaired, renally impaired, probably get some IP maybe out of our human abuse potential study.

還有一些其他申請正在被起訴，涉及我們圍繞該標籤所做的其他臨床工作，例如老年人或肝功能受損、腎功能受損的患者的劑量，可能會從我們的人類濫用潛力研究中獲得一些知識產權。

So those kinds of patents that are being prosecuted now would actually extend this out to one group's 2041 and one group's 2043. But I think of this sort of the core of the patent coverage through this method of treatment 2039.

因此，現在正在起訴的此類專利實際上將其擴展到一組的 2041 和一組的 2043。但我認為這種專利覆蓋率的核心是透過這種處理方法2039。

As for refractory chronic cough, that broadly falls under the same umbrella. We're waiting for our data out of this RIVER study, and then we'll prosecute the actual claims around the data we saw, file them as track one claims, and those should be issued as well.

至於難治性慢性咳嗽，大致上屬於同一類。我們正在等待這項 RIVER 研究的數據，然後我們將根據我們看到的數據起訴實際索賠，將它們歸檔為第一軌道索賠，這些索賠也應該發布。

We wrote the overall invention with it in mind that we would be looking at IPF, other interstitial lung diseases, and refractory chronic cough. And we pull from that application when we get actual data to get the claims issued.

我們編寫整個發明時考慮到我們將關注 IPF、其他間質性肺部疾病和難治性慢性咳嗽。當我們獲得實際數據時，我們會從該應用程式中提取數據以發出索賠。

Great. Sounds good. And just a quick follow-up. If you could discuss the current patient population with regard to RCC in terms of how many are diagnosed and how many are currently seeking treatment, just to provide a little granularity on that? Thanks.

偉大的。聽起來不錯。只是快速跟進。您是否可以討論目前 RCC 的患者群體，包括有多少人被診斷出來以及有多少人目前正在尋求治療，只是為了提供一些詳細資訊？謝謝。

Yeah. Good question. And we have some of this in our corporate deck, and I don't have my commercial colleague on. We believe there's about 2 million to 3 million treatable patients in the US. It's a big indication. I think there's roughly 7 million patients diagnosed in the US.

是的。好問題。我們的公司甲板上有一些這樣的內容，但我沒有讓我的商業同事參加。我們相信美國大約有 200 萬到 300 萬可治療的患者。這是一個很大的跡象。我認為美國大約有 700 萬名患者被確診。

But when you sort of work that down of people who are looking for treatment and not getting proper care, sort of it brings its way down to about 2 million to 3 million patients. But if you want to, John, we can follow up on that, and I can have Farrell join the call, and we can give you a better walk-down.

但是，當你對那些正在尋求治療但沒有適當護理的人進行分類時，你會發現大約有 200 萬到 300 萬患者。但如果你願意，約翰，我們可以跟進此事，我可以讓法雷爾加入通話，我們可以為你提供更好的訪問。

Debanjana Chatterjee, JonesTrading.

Debanjana Chatterjee，瓊斯交易公司。

Yes. Okay. I was kind of curious, like, how long of a delay do you anticipate to the RCC readout because of this imbalance? And I have a follow-up question.

是的。好的。我有點好奇，例如，由於這種不平衡，您預計 RCC 讀數會延遲多長時間？我還有一個後續問題。

I don't -- I mean, sitting here today, I don't expect any delay. We've confirmed -- reaffirmed our guidance for the fourth quarter of this year. We are 80% enrolled. So I just only bring up the issue because if we get to the end and want to hold the trial open for, I mean, we're not going to hold it open for more than a month or two at the most to get these arms in balance. And it may not even -- that may not even be required. So at this point, I don't expect any delay. I'm just pointing out that that wasn't a part of our protocol we really wanted to try to execute on to get the information.

我不——我的意思是，今天坐在這裡，我預計不會有任何延誤。我們已經確認並重申了我們對今年第四季的指導。我們的入學率是80%。所以我只是提出這個問題，因為如果我們走到最後並希望繼續進行審判，我的意思是，我們最多不會將其開放超過一兩個月才能獲得這些武器處於平衡狀態。甚至可能不需要。因此，目前我預計不會有任何延遲。我只是指出，這不是我們真正想要嘗試執行以獲取資訊的協議的一部分。

Yes. That's very helpful. Thank you. And maybe one other question. As you mentioned that, it's -- I mean, in case you decide to lead the -- I mean, and execute, like, the RCC program on your own, like, you could be considering like in third line. How big do you think the opportunity size is there? How many -- like, what's the number of patients?

是的。這非常有幫助。謝謝。也許還有另一個問題。正如您所提到的，我的意思是，如果您決定領導 - 我的意思是，您自己執行 RCC 計劃，您可以考慮在第三行。您認為機會有多大？有多少——比如，病人有多少？

Yeah. So we have not shared all of that. We're doing a lot of work this summer. It's a big patient opportunity. I mean, with a lot of the P2X3s. I know you followed that space, Debanjana. They don't work in sort of 30% to 40% of the patients. Some of the patients they work in have very severe cough, and even then, with the reduction in cough, it's not completely reduced. So there's a pretty big opportunity here for this group with really not a lot of options.

是的。所以我們還沒有分享所有這些。今年夏天我們做了很多工作。這是一個很大的患者機會。我的意思是，有很多 P2X3。我知道你有關注那個空間，Debanjana。它們對 30% 到 40% 的患者不起作用。他們治療的一些患者咳嗽非常嚴重，即使咳嗽減少了，咳嗽也沒有完全減少。因此，對於這個群體來說，有一個相當大的機會，但實際上沒有太多選擇。

So we are finishing up our market research. And at some point, we'll share sort of our views on that and how that walks down. But we view that as a very significant market opportunity, particularly in light of the fact there's very little -- there's not a lot of competitors left in the space.

所以我們正在完成我們的市場調查。在某個時候，我們將分享我們對此以及如何進行的看法。但我們認為這是一個非常重要的市場機會，特別是考慮到這個市場機會很少——該領域的競爭對手已經不多了。

This concludes our question-and-answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.

我們的問答環節到此結束。我想將會議轉回給詹妮弗·古德致閉幕詞。

Thank you for joining us. We are expecting steady news flow of data in the upcoming months with regards to our clinical trials data and we look forward to sharing this with you. We will be participating in several investor conferences over the next couple of months, as listed in our press release, and hopefully, we will see some of you there. Thank you for joining the call and we're available afterwards for any questions you may have.

感謝您加入我們。我們預計在接下來的幾個月將有關於我們的臨床試驗數據的穩定的新聞數據流，我們期待與您分享。正如我們的新聞稿中所列，我們將在接下來的幾個月內參加幾次投資者會議，希望我們能在那裡見到你們中的一些人。感謝您參加此電話會議，之後我們將隨時為您解答任何問題。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。